Amend the information in a previously approved protocol application by directly changing the appropriate data fields or amending the available attachments. All updates to the previously approved application must be completed in the appropriate section of the Protocol record to ensure a complete and final protocol is reviewed. Only those sections with updated information must be updated for submission of the new Amendment.

NOTE: If sections or fields cannot be edited, review the "Amendment Summary" screen found in the Create Submission section to ensure the appropriate section's checkbox is checked.

Amend Section 1: Protocol Details

NOTE: To revise the previously approved Investigators/Study Personnel, either add or remove named individuals just as you would when initially creating the submission.

1. Click on the appropriate screen link in the Left Navigation

2. Make all appropriate changes to the desired data fields

3. Click “Save” at the bottom of each screen you have revised

NOTE: For further instructions on how to complete or update the screens found in Section 1: Protocol Details, see the Protocol Details screens in the Initial Protocol Submission section of the online Investigator User Manual.

Amend Section 2: Questionnaires

1. Go to section 2: Questionnaires and click the first identified Questionnaire to revise

2. Click “Modify” at top of completed Questionnaire

3. Click “Save & Proceed” until you get to first question needing revisions

4. Make all appropriate changes as desired

5. Repeat steps 3 & 4 for all questions to revise

6. When all Questionnaire revisions are complete, click the “Save & Complete” button to finish edits

7. Questionnaire Completion message will display and click “Ok” to navigate to and complete the next applicable Questionnaire that needs revisions

Amend Section 3: Attachments

IMPORTANT: Attachments uploaded into CoeusLite records CANNOT be modified within the system. Attachments must be kept outside of Coeus or downloaded to desktop for editing and then re-uploaded.

1. Go to section 3: Attachments, click the “Attachments” link

2. Locate appropriate Attachment that needs updated from the Attachments in Original Protocol list

3. Click the “View” button next to the Attachment

4. Save the previously submitted document to your desktop if it is not already saved

5. Open the document from desktop and make all appropriate changes. Be sure to HIGHLIGHT changed information

6. When revisions are complete, go back to the Attachments screen in CoeusLite. Click the “Amend” link next to the Attachment to revise